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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 7 5MM ATTUNE IMPLANT : KNEE TIBIAL INSERT

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DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 7 5MM ATTUNE IMPLANT : KNEE TIBIAL INSERT Back to Search Results
Catalog Number 151620705
Device Problem Noise, Audible (3273)
Patient Problems Pain (1994); Synovitis (2094); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Event Date 11/05/2018
Event Type  Injury  
Manufacturer Narrative
Product complaint (b)(4). Initial reporter occupation: lawyer. (b)(4). If information is obtained that was not available for the.
 
Event Description
Attune claim record received. Claim record alleges severe and persistent pain, discomfort, instability, popping and clicking of her device, difficulty ambulating and loosening of the tibial component at an unknown interface. Unknown cement was used. Doi: (b)(6) 2015. Dor: (b)(6) 2018. Left knee.
 
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary
==
> no device associated with this report was received for examination. A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand NameATTUNE CR FB INSRT SZ 7 5MM
Type of DeviceATTUNE IMPLANT : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY RAYNHAM A. DIV. OF DEPUY ORTHO 1219655
325 paramount drive
raynham MA
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key9511203
MDR Text Key185191813
Report Number1818910-2019-124551
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101433
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 12/04/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Catalogue Number151620705
Device Lot Number623377
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/06/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/23/2019 Patient Sequence Number: 1
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